Uchiike Akihiro, Kono Haruka, Miura Katsuhiro, Hayama Tatsuya, Tsutsumi Daisuke, Tsuboi Shinya, Ohtsuka Susumu, Hidaka Shinji
Nihon University Itabashi Hospital Tumor Center, 30-1 Oyaguchikamicho, Itabashi, 173-8610, Tokyo, Japan.
Department of Pharmacy, Nihon University Itabashi Hospital, Tokyo, Japan.
J Pharm Health Care Sci. 2023 Aug 1;9(1):24. doi: 10.1186/s40780-023-00293-y.
Olanzapine treatment prevents chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). However, its role in the secondary prevention of breakthrough CINV in real-world cancer care should be further evaluated.
We conducted a retrospective study on patients receiving olanzapine to prevent breakthrough CINV refractory to standard antiemetic therapy. The major outcome was improvement in CINV, defined as any downgrade in CINV symptoms, according to the Common Terminology Criteria for Adverse Events. Comprete response was defined as no symptoms in CINV, i.e., Grade 0. These outcomes were compared in the HEC versus non-HEC groups and the standard- (5 or 10 mg/day) versus low- (2.5 mg/day) dose groups. The other outcome measurement was adverse events (AEs).
We analyzed 127 patients, including 92 women, with a median age of 50 years (range: 19-89 years). Baseline CINV severity was grade 1, 2, and 3 in 18%, 69%, and 13% of the patients, respectively. After prophylaxis with olanzapine at doses of 2.5, 5, or 10 mg/day, improvement was observed in 105 (83%) patients, with a complete response in 42 patients (33%). The improvement and complete remission rates for the HEC (n = 96) and non-HEC (n = 31) groups were 86% and 71% (p = 0.048) versus 38% and 19% (p = 0.062), respectively. The rates for the standard- (n = 98) and low- (n = 29) dose groups were 86% and 82% (p = 0.568) versus 28% and 52% (p = 0.015), respectively. Thirty-four patients (27%) experienced olanzapine-related AEs, mainly somnolence (n = 28). Grade 3 or higher AEs were not observed.
Our study results support the clinical application of olanzapine for the secondary prevention of breakthrough CINV.
奥氮平治疗可预防接受高致吐性化疗（HEC）患者的化疗引起的恶心和呕吐（CINV）。然而，其在现实世界癌症护理中对突破性CINV二级预防的作用仍有待进一步评估。
我们对接受奥氮平预防标准止吐治疗难治性突破性CINV的患者进行了一项回顾性研究。主要结局是CINV的改善，根据不良事件通用术语标准，定义为CINV症状的任何降级。完全缓解定义为CINV无症状，即0级。在HEC组与非HEC组以及标准剂量（5或10mg/天）与低剂量（2.5mg/天）组中比较这些结局。另一个结局指标是不良事件（AE）。
我们分析了127例患者，其中包括92名女性，中位年龄为50岁（范围：19 - 89岁）。基线时，分别有18%、69%和13%的患者CINV严重程度为1级、2级和3级。在接受2.5、5或10mg/天剂量奥氮平预防后，105例（83%）患者症状改善，42例（33%）患者完全缓解。HEC组（n = 96）和非HEC组（n = 31）的改善率和完全缓解率分别为86%和71%（p = 0.048）以及38%和19%（p = 0.062）。标准剂量组（n = 98）和低剂量组（n = 29）的改善率分别为86%和82%（p = 0.568）以及28%和52%（p = 0.015）。34例患者（27%）出现与奥氮平相关的AE，主要是嗜睡（n = 28）。未观察到3级或更高等级的AE。
我们的研究结果支持奥氮平在突破性CINV二级预防中的临床应用。
